AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]

AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]
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NDC 43749-430-12, 43749-430-13
Set ID 4defc910-1f4b-4a87-8bdd-9d71d8cadd93
Category HUMAN OTC DRUG LABEL
Packager Unipack, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • Drug Facts

    Active Ingredients                                                                        Purpose

    Cocoa butter 88.50%...................................................................Protectant

    Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily relieves burning and shrinks hemorrhoidal tissue
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For rectal use only

  • Ask a doctor or pharmacist before use if you are

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

  • Ask a doctor before use if you have

    Ask a doctor before use if you have
    -heart disease    -high blood pressure

    -thyroid disease   -diabetes

    -difficulty in urination due to enlargement of the prostate gland

  • When using this product

    When using this product do not exceed the recommended daily dosage unless directed by a doctor

  • Stop use and ask a doctor 

    Stop use and ask a doctor if bleeding occurs or if condition worsens or does not improve within 7 days

  • If pregnant or breastfeeding

    If pregnant or breastfeeding, ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions: Adults

    Directions: Adults

    -when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.

    -detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

    -hold suppository with rounded end up

    -as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"

    -slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose from wrapper

    -insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

    -children under 12 years of age: ask a doctor

  • Other information

    Store at 20oC-25oC (68oF-77oF)

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • Label

    LabelLabelLabelLabel

  • INGREDIENTS AND APPEARANCE
    AVEDANA HEMORRHOIDAL 
    hemorrhoidal rectal suppositories suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-430
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER88.5 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE.26 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T) .02 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .02 g  in 100 g
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.2 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-430-132 in 1 CARTON09/17/2017
    1NDC:43749-430-1212 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/18/2014
    Labeler - Unipack, Inc. (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(43749-430)

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